UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047645 |
|---|---|
| Receipt number | R000054330 |
| Scientific Title | A feasibility study on a smartphone application for binge eating in patients with eating disorders |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/11/03 11:24:28 |
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Basic information
Public title
A feasibility study on a smartphone application for binge eating in patients with eating disorders
Acronym
A feasibility study on a smartphone application for binge eating in patients with eating disorders
Scientific Title
A feasibility study on a smartphone application for binge eating in patients with eating disorders
Scientific Title:Acronym
A feasibility study on a smartphone application for binge eating in patients with eating disorders
Region
| Japan |
Condition
Condition
Eating disorders
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of a smartphone application for binge eating in patients with eating disorders.
Basic objectives2
Others
Basic objectives -Others
Nothing in particular
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 4 weeks after the start of the intervention
- Completion rate
- Continuous application use days
Key secondary outcomes
At 4 weeks after the start of the intervention
- Evaluation of the usability of the application
- Bulimic Investigatory Test, Edinburgh (BITE)
- Eating Disorder Examination Questionnaire (EDE-Q)
- Eating Disorders Quality of Life (ED-QOL)
- Number of binge eating within a week
- Number of purging behaviors within a week
- Emotion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
4 weeks of standard treatment with a smartphone application
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients >= 16 years old in outpatient treatment for the following diagnoses based on DSM-5 criteria
- Anorexia nervosa (with binge eating symptoms)
- Bulimia nervosa
- Binge eating disorder
Key exclusion criteria
- Patients with severe physical or mental diseases
- When the burden of investigation is considered undesirable for the medical condition
- Patients who seem to lack the ability to make decisions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshiuchi |
Organization
The University of Tokyo Hospital
Division name
Department of Psychosomatic Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9764
kyoshiuc-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kurisu |
Organization
The University of Tokyo Hospital
Division name
Department of Psychosomatic Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9764
Homepage URL
chrischris0801@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
